Tooth DiseaseNCT03423784
Performance and Tolerability of a New Medical Device Gel, a Randomized, Open Label, Parallel-group, Multicentre Study
A study testing HA BPX V3.3 and Dentinox-Gel N in people with Tooth Disease, run by Opera CRO, a TIGERMED Group Company.
Trial summary
Medical device study for efficacy and tolerability of a HA gel in the management of teething symptoms Read more about this study
- Who is it for?
- Ages 3 to 36 months
- Conditions the study is for
- Tooth Disease
- What is being tested?
- HA BPX V3.3 and Dentinox-Gel N
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2013to 30 Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female infants aged between 3 and 36 months.
- Teething diagnosed by the presence of at least 3 of the following clinical symptoms:
- pain
- swelling
- hyper-salivation
- redness
Show all 10Show fewer
- abnormal teeth depth.
- At the moment of inclusion no subcutaneous mucosal laceration must be yet appeared.
- Infants and parents who are in a general position to follow all study requirements.
- Informed consent form signed by parents or legal representative.
Who cannot join
- Infants in hospitalization and/or immobilization and/or confinement to bed.
- Infants with known history of severe renal insufficiency and/or known history of severe cardiac dysfunction and/or liver problems.
- Use of topical oral Lidocaine, other topical oral anesthetic products and/or topical Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) within one day before inclusion.
- Use of systemic NSAIDs within 3 days before inclusion and/or use of systemic anesthetics within 10 days before.
- Concomitant use during the period of study of NSAIDs and/or any other anesthetics (except Dentinox®-Gel N, for subjects allocated to group II of treatment).
- Subjects with known family history of allergic or adverse reactions to drugs or substances.
- Infants whose parents suffer from any form of psychiatric disorder or other condition which, in the opinion of the Investigator, might invalidate the required prescription and/or observation or complicate communication with the subject.
- Infants simultaneously participating or having participated in the last month before Visit 1 in another clinical trial.
About this study
Official title: Performance and Tolerability of a New Medical Device Coating Gel for the Temporary Relief of Teething Symptoms: a Randomized, Open Label, Parallel-group, Multicentre Study
Medical device study for efficacy and tolerability of a HA gel in the management of teething symptoms
Read the detailed description
Due to the potential toxicity that can result from the use of topical anesthetics to relieve the symptoms associated with gingival inflammatory conditions or gums trauma in infant, recently, products containing Hyaluronic Acid (HA) have been marketed in Europe. In particular, Bioplax Limited is developing several high molecular weight HA medical devices characterized by the absence of preservatives, alcohol and dyes; therefore, the administration of these products in infants is safe and can help creating a natural protective layer on the gingival tissue. In previous clinical trials with these high molecular weight HA medical devices it was noted a periodontal tissue/fluid balance with accelerated healing and repair properties that could be of interest either for accelerating the wound healing process or for treating the complex physical symptoms (i.e. soreness and swelling of gums, crying, sleeplessness) related to the teething in infants. These data were confirmed by a recent pilot study on 18 infants suffering by teething where the two formulation of the tested high molecular weight HA medical device evidenced, at the end of treatment period, a statistically significant reduction of pain, swelling, gingival rush, hyper-salivation and redness, from baseline.
- Conditions
- Tooth Disease
- Being tested
- HA BPX V3.3, Dentinox-Gel N
- Keywords
- teething in infants and children, oral gels, paediatric dentistry
- Medical subject headings
- Tooth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HA BPX V3.3Device
medical device containing HA
Dentinox-Gel NOther
Anaesthetic gel
| Study group | Role | What they receive |
|---|---|---|
| HA BPX V3.3 | Experimental | A HMWHA gel available in a formulation specificaly designed for use in infants Receives: Device: HA BPX V3.3 |
| Dentinox-Gel N | Active comparator | Gold standard for teething symptoms Receives: Other: Dentinox-Gel N |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in gingival swelling
Face, Legs, Activity, Cry and Consolability Pain Assesment Scale
Measured: 3 days
Secondary outcomes (1)
changes in crying
Face, Legs, Activity, Cry and Consolability Pain Assesment Scale
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start15 Nov 2013
- Primary completion31 Mar 2015
- Study completion30 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Opera CRO, a TIGERMED Group Company
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rosu Serban, MD, Principal investigator, SCM Dr. ROSU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03423784
- Sponsor's protocol ID
- BPX11-13
- Status last verified
- May 2018
- First submitted
- 26 Jan 2018
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance and Tolerability of a New Medical Device Coating Gel for the Temporary Relief of Teething Symptoms: a Randomized, Open Label, Parallel-group, Multicentre Study
- ClinicalTrials.gov ID
- NCT03423784
- Acronym / sponsor ID
- BPX11-13
- Conditions
- Tooth Disease
- Keywords
- teething in infants and children, oral gels, paediatric dentistry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Opera CRO, a TIGERMED Group CompanyUniversity, hospital or other
- Study start
- 15 Nov 2013 (actual)
- Primary completion
- 31 Mar 2015 (actual)
- Study completion
- 30 Jun 2015 (actual)
- First posted
- 6 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Medical device study for efficacy and tolerability of a HA gel in the management of teething symptoms
Detailed description
Due to the potential toxicity that can result from the use of topical anesthetics to relieve the symptoms associated with gingival inflammatory conditions or gums trauma in infant, recently, products containing Hyaluronic Acid (HA) have been marketed in Europe. In particular, Bioplax Limited is developing several high molecular weight HA medical devices characterized by the absence of preservatives, alcohol and dyes; therefore, the administration of these products in infants is safe and can help creating a natural protective layer on the gingival tissue. In previous clinical trials with these high molecular weight HA medical devices it was noted a periodontal tissue/fluid balance with accelerated healing and repair properties that could be of interest either for accelerating the wound healing process or for treating the complex physical symptoms (i.e. soreness and swelling of gums, crying, sleeplessness) related to the teething in infants. These data were confirmed by a recent pilot study on 18 infants suffering by teething where the two formulation of the tested high molecular weight HA medical device evidenced, at the end of treatment period, a statistically significant reduction of pain, swelling, gingival rush, hyper-salivation and redness, from baseline.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HA BPX V3.3 | Experimental | Device: HA BPX V3.3A HMWHA gel available in a formulation specificaly designed for use in infants |
| Dentinox-Gel N | Active comparator | Other: Dentinox-Gel NGold standard for teething symptoms |
Who may qualify
- Ages
- 3 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Male or female infants aged between 3 and 36 months.
- Teething diagnosed by the presence of at least 3 of the following clinical symptoms:
- At the moment of inclusion no subcutaneous mucosal laceration must be yet appeared.
- Infants and parents who are in a general position to follow all study requirements.
- Informed consent form signed by parents or legal representative.
Key exclusion criteria (8 listed)
- Infants in hospitalization and/or immobilization and/or confinement to bed.
- Infants with known history of severe renal insufficiency and/or known history of severe cardiac dysfunction and/or liver problems.
- Use of topical oral Lidocaine, other topical oral anesthetic products and/or topical Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) within one day before inclusion.
- Use of systemic NSAIDs within 3 days before inclusion and/or use of systemic anesthetics within 10 days before.
- Concomitant use during the period of study of NSAIDs and/or any other anesthetics (except Dentinox®-Gel N, for subjects allocated to group II of treatment).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HA BPX V3.3medical device containing HA | Device | HA BPX V3.3 |
| Dentinox-Gel NAnaesthetic gel | Other | Dentinox-Gel N |
Primary outcome
changes in gingival swelling
Time frame: 3 days
Face, Legs, Activity, Cry and Consolability Pain Assesment Scale
1 secondary outcome
changes in crying
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosu Serban, MD principal investigator
SCM Dr. ROSU
Questions about this trial
What is this clinical trial studying?
A study testing HA BPX V3.3 and Dentinox-Gel N in people with Tooth Disease, run by Opera CRO, a TIGERMED Group Company.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in gingival swelling (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2018.